Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)

This study has been withdrawn prior to enrollment.
(Study has never received funding and has never been initiated)
Sponsor:
Collaborator:
Center for Research on Women and Newborn Health
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00123175
First received: July 20, 2005
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

The purpose of this research is to determine the effectiveness of the intrauterine device (IUD) called Mirena when compared to the Provera tablets used in treating this condition.


Condition Intervention Phase
Endometrial Hyperplasia
Device: Intrauterine Device
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Levonorgestrel Containing Intrauterine Device in the Treatment of Endometrial Hyperplasia Without Atypia

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Pathologic examination of the specimens obtained by endometrial biopsy to determine the regression of endometrial hyperplasia without atypia compared to Provera [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Bleeding profile [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Estradiol and progesterone levels [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Intrauterine Device
    Mirena and Provera
    Other Name: Medroxyprogesterone Acetate and Progestins
Detailed Description:

Endometrial hyperplasia without atypia is a condition usually caused by excessive stimulation of the uterine lining (endometrium) by estrogens, and may cause irregular bleeding as a presenting symptom, but rarely may progress to endometrial cancer, which makes treatment important. The only treatment approved so far is medroxyprogesterone acetate tablets (progesterone), also known as Provera.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Histologic diagnosis of simple or complex endometrial hyperplasia without atypia
  • Normal pap smear within one year

Exclusion Criteria:

  • Diabetes
  • Family history of endometrial cancer
  • Contraindications for the intrauterine device
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123175

Sponsors and Collaborators
Milton S. Hershey Medical Center
Center for Research on Women and Newborn Health
Investigators
Principal Investigator: Richard Legro, M.D. Penn State University College of Medicine
  More Information

No publications provided

Responsible Party: Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00123175     History of Changes
Other Study ID Numbers: 21012
Study First Received: July 20, 2005
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Endometrial Hyperplasia without atypia

Additional relevant MeSH terms:
Endometrial Hyperplasia
Hyperplasia
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Medroxyprogesterone
Medroxyprogesterone Acetate
Progestins
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 21, 2014